Abstract
BACKGROUND: Intervertebral body fusion devices (IBFDs) are a widely used type of spinal implant placed between two vertebral bodies to stabilize the spine for fusion in the treatment of spinal pathologies. Assessing mechanical performance of these devices is critical during the design, verification, and regulatory evaluation phases of development. While traditionally evaluated with physical bench testing, empirical assessments are at times supplemented with computational models and simulations such as finite element analysis (FEA). However, unlike many mechanical bench tests, FEA lacks standardized practices and consistency of implementation. OBJECTIVES: The objectives of this study were twofold. First, to identify IBFD 510(k) submissions containing FEA and conduct a comprehensive review of the elements provided in the FEA reports. Second, to engage with spinal device manufacturers through an anonymous survey and assess their practices for implementing FEA. METHODS: First, a retrospective analysis of 510(k) submissions for IBFDs cleared by the FDA between 2013 and 2017 was performed. The contents of FEA test reports were quantified according to FDA guidance. Second, a survey inquiring about the use of FEA was distributed to industry and academic stakeholders. The survey asked up to 20 questions relating to modeler experience and modeling practices. RESULTS: Significant gaps were present in model test reports that deemed the data unreliable and, therefore, unusable for regulatory decision-making in a high percentage of submissions. Nonetheless, the industry survey revealed most stakeholders employ FEA during device evaluation and are interested in more prescriptive guidelines for executing IBFD models. CONCLUSIONS: This study showed that while inconsistencies and gaps in FEA execution do exist within the spinal device community, the stakeholders are eager to work together in developing standardized approaches for executing computational models to support mechanical performance assessment of spinal devices in regulatory submissions.